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Exploratory study in view of a Critical Medicines Act
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Exploratory study in view of a Critical Medicines Act

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The exploratory study supports the European Commission’s efforts to address medicines’ shortages in view of a Critical Medicines Act. The analysis is carried out against the backdrop of the current EU legislative and policy context, chiefly the Pharmaceutical Strategy for Europe – including the revision of the general pharmaceutical legislation – and the strengthening of the role of the European Medicines Agency. The study reviews the dynamics of the EU pharmaceutical market before the in-depth analysis of the main problem drivers of critical medicine shortages in the EU. Those include manufacturing issues, unexpected demand fluctuation, commercial reasons, quality issues, regulatory issues and unpredicted major events or natural disasters. The analysis considers supply chain vulnerabilities, disruptions as well as external factors such as pricing and public procurement practices. After considering the baseline scenario, including existing gaps, the study assesses and compares three alternative policy options, evaluating their economic, social, and environmental impacts, and offers a tailored monitoring and indicators framework.
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ISBN 978-92-9413-015-0
DOI 10.2929/7587553
Catalogue number LN-01-25-003-EN-N
ISBN 978-92-9413-016-7
DOI 10.2929/9890843
Catalogue number LN-01-25-003-EN-C
PDF
ISSN ISBN 978-92-9413-015-0 DOI 10.2929/7587553 Catalogue number LN-01-25-003-EN-N
Paper
ISSN ISBN 978-92-9413-016-7 DOI 10.2929/9890843 Catalogue number LN-01-25-003-EN-C
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